公开(公告)号：US5320853A

公开(公告)日：1994-06-14

申请号：US995309

申请日：1992-12-22

申请人： Kazuo Noda ,  Yoshiyuki Hirakawa ,  Hiroyuki Yoshino ,  David D. MacLaren ,  Paul F. Skultety ,  John R. Lefler ,  Greg M. Beck

发明人： Kazuo Noda ,  Yoshiyuki Hirakawa ,  Hiroyuki Yoshino ,  David D. MacLaren ,  Paul F. Skultety ,  John R. Lefler ,  Greg M. Beck

IPC分类号： A61K9/52 ,  A61K9/50 ,  A61K9/54 ,  A61K9/58 ,  A61K31/554 ,  A61K47/12 ,  A61K47/20 ,  A61P9/12 ,  A61K9/24

CPC分类号： A61K9/5078

摘要： Controlled release pharmaceutical beads are provided having a multi-layered core and a multi-layered periphery. The core contains at least (A) an inner portion having a suitable organic acid and (B) a sustainably-acid-releasing coating thereover. The periphery contains at least (A) an inner portion having a mixture of at least (i) a pharmaceutical compound and (ii) a surface-active agent, and (B) a sustainably-drug-releasing exterior coating.

摘要翻译： 提供具有多层芯和多层外围的控释药物珠粒。 核心至少包含（A）具有合适的有机酸的内部部分和（B）其上可持续发酸的涂层。 外围至少包含（A）具有至少（i）药物化合物和（ii）表面活性剂的混合物的内部部分，和（B）可持续释放药物的外部涂层。

公开(公告)号：US6039974A

公开(公告)日：2000-03-21

申请号：US127478

申请日：1998-07-31

申请人： David D. MacLaren ,  John R. Lefler ,  Sharon K. Minish

发明人： David D. MacLaren ,  John R. Lefler ,  Sharon K. Minish

IPC分类号： A61K9/20 ,  A61K9/22 ,  A61K9/24 ,  A61K31/445 ,  A61K45/00 ,  A61K45/06 ,  A61K47/04 ,  A61K47/12 ,  A61K47/38 ,  A61K47/44 ,  A61P11/02 ,  A61P11/08 ,  A61P37/08 ,  A61P43/00 ,  A61K9/28

CPC分类号： A61K9/209 ,  A61K31/445 ,  A61K9/2013 ,  A61K9/2054 ,  Y10S514/853

摘要： The present invention provides a pharmaceutical composition in the form of a bilayer tablet comprising,(a) a first discrete zone made with Formulation (A) which comprises, a therapeutically effective decongestant amount of a sympathomimetic drug, or a pharmaceutically acceptable salt thereof, in an amount of about 18% to about 39% by weight of Formulation (A), and a first carrier base material, the first carrier base material comprising a mixture of;(I) carnauba wax in an amount of about 59% to about 81% by weight of Formulation (A); and(ii) a suitable antiadherent in an amount of about 0.25% to about 2.00% by weight of Formulation (A);wherein said first carrier base material provides a sustained release of the sympathomimetic drug; and(b) a second discrete zone made with Formulation (B) which comprises a therapeutically effective antihistaminic amount of a piperidinoalkanol, or a pharmaceutically acceptable salt thereof, in an amount of about 15% to about 30% by weight of Formulation (B) and a second carrier base material, the second carrier base comprising a mixture of;(I) a cellulose diluent in an amount of about 27% to about 73% by weight of Formulation (B);(ii) pregelatinized starch in an amount of about 15% to about 30% by weight of Formulation (B);(iii) a suitable disintegrant in an amount of about 0.25% to about 6.00% by weight of Formulation (B); and(iv) a suitable lubricant in an amount of about 0.25% to about 2.00% by weight of Formulation (B);wherein said second carrier base material provides an immediate release of the piperidinoalkanol or the pharmaceutically acceptable salt thereof.

摘要翻译： 本发明提供了一种双层片剂形式的药物组合物，其包含：（a）由制剂（A）制成的第一离散区，其包含治疗有效的减充血剂量的拟交感神经药物或其药学上可接受的盐， 约占制剂（A）的约18重量％至约39重量％的第一载体基材，第一载体基材包含混合物; （I）巴西棕榈蜡的量为制剂（A）的约59％至约81％重量; 和（ii）配方（A）的约0.25重量％至约2.00重量％的合适的抗粘附剂; 其中所述第一载体基材提供所述拟交感神经药物的持续释放; （B）由制剂（B）制成的第二离散区，其包含治疗有效的抗组胺量的哌啶子基链烷醇或其药学上可接受的盐，其量为制剂（B）的约15重量％至约30重量％ 和第二载体基材，所述第二载体基底包括： （I）配方（B）的约27％至约73％重量的纤维素稀释剂; （ii）预胶化淀粉，其量为制剂（B）的约15重量％至约30重量％; （iii）配方（B）的约0.25％至约6.00％重量的合适的崩解剂; 和（iv）配方（B）的约0.25％至约2.00％重量的合适润滑剂; 其中所述第二载体基料提供哌啶子基链烷醇或其药学上可接受的盐的即时释放。